Table 7c Applications with Interim Recommendations*

TransUrethral Needle Ablation for benign prostatic hyperplasia

Relatively safe

Relatively effective procedure for the short-term management

Additional clinical data is required

Limited role as an alternative treatment for symptomatic benign prostatic hyperplasia with the following restrictions: men with moderate to severe lower urinary tract symptoms that require specific treatment (ie those who would normally be recommended for TURP); not be medically suitable for TURP.

Surgical

Directional, vacuum-assisted breast biopsy

Safe

Seems to be more effective

Not undertaken

Currently claimable under the MBS. The costs associated with the procedure should be investigated; and pending review of the costs, the procedure should receive interim funding at a higher remuneration than is currently available under existing items for nonpalpable breast lesions.

Diagnostic

Near patient cholesterol testing using the Cholestech LDX

Safe

Improved diagnostic accuracy over conventional

Problematic due to uncertainties

The unrestricted use of near patient cholesterol testing using the Cholestech LDX is not recommended. The restricted use of near patient cholesterol testing, as an alternative to laboratory testing of lipids, should be considered in settings or circumstances where there is adequate training, accreditation and quality assurance.

Diagnostic

Brachytherapy for the treatment of prostate cancer

May offer less risk

There has not been a successful randomised controlled trial

Slightly higher direct budgetary costs but may involve less indirect costs

Patients with prostate cancer at clinical stages T1, T2a or T2b, with Gleason Scores of less than or equal to 6, prostate specific antigen (PSA) of less than or equal to 10 ng/ml, a gland volume less than 40 cc and with a life expectancy of more than 10 years; and where the treatment is conducted at approved sites.

Surgical

Deep brain stimulation for symptoms of advanced Parkinson's disease

limited evidence suggests

Some evidence – more long-term studies of improved methodological quality are needed.

Costs more than alternative over 5 years.

For patients where their response to medical therapy is not sustained and is accompanied by unacceptable motor fluctuations; and subject to the patients' participation in an appropriate controlled trial to obtain information on adverse events, longer-term patient outcomes and costs in the Australian setting.

Surgical

Intravascular Brachytherapy – Commercial-in-Confidence application

Acceptable

Based on level II and III-3 evidence.

Estimated to be approximately $31,500 per TLR prevented.

There is insufficient evidence on the safety and effectiveness of implanting radioactive stents to support public funding for this procedure. The short- and medium-term data on the safety and effectiveness of catheter based intravascular brachytherapy for the treatment of coronary artery restenosis is sufficient to warrant interim funding for this procedure.

Surgical

Hyperbaric Oxygen Therapy (Resubmission)

Adverse events self-limited and resolved after termination of therapy

RCT evidence was of low methodological quality, failing to meet relevant validity criteria.

Clinical evidence was inadequate to substantiate claims that (HBOT) was cost-effective.

The clinical evidence was inadequate to substantiate claims that hyperbaric oxygen therapy (HBOT) was cost-effective in the treatment of refractory soft tissue radiation injuries or non-diabetic refractory wounds. However, MSAC recommended that, as there are no effective alternative therapies and in view of the progress of local data collections and an international trial, funding for HBOT continue.

Therapeutic

M2A® capsule endoscopy for the evaluation of obscure gastrointestinal bleeding in adult patients

Infrequent and mild adverse events.

Little available data on this technology's effect on patient management and long-term clinical outcomes.

Lower total health care costs overall.

Funding should be supported for this procedure for patients with confirmed recurrent obscure gastrointestinal bleeding following previous colonoscopy and endoscopy without identifying bleeding source.

Diagnostic

Sentinel Node Biopsy for Breast Cancer

Appears to be safe

Long term outcomes are uncertain

Based on cost minimisation, the cost to avoid lymphoedema. Therefore, the procedure appeared cost-effective.

Long term outcomes are uncertain. Funding for sentinel node biopsy should be provided pending the outcome of trials already in progress and should be reviewed in five years.

Diagnostic – Biopsy

SIR-Spheres® for the treatment of non-resectable liver tumours

Patients with hepatic metastases secondary to colorectal cancer which are not suitable for resection or ablation. Not funded for non-resectable, non-ablatable hepatocellular carcinoma.

Therapeutic

Brachytherapy for the treatment of prostate cancer

Unchanged from 1029

Unchanged from 1029

Unchanged from 1029

As a result of re-assessment of further evidence – interim public funding should continue for patients with prostate cancer at clinical stages T1 and T2 with Gleason Scores of less than or equal to 6, prostate specific antigen (PSA) of less than or equal to 10 ng/ml, gland volume less than 40 cc and with life expectancy of more than 10 years.

Surgical